An improved Improver? - Part 2

Here as promised is the second part of this GuestKat's commentary on Eli Lilly v Actavis UK [2017] UKSC 48, which promises to have much ink spilled and air of various temperatures emitted on its behalf in the coming weeks, months and years. As noted in the first post, the Supreme Court reformulated the Improver questions, originally posed by Lord Hoffmann when at first instance and subsequently further evaluated by him in the House of Lords in Kirin-Amgen, which thoroughly examined the UK approach to patent claims. This GuestKat has regarded Lord Hoffmann's judgment in that case as a definitive guide to interpretation and construction and it is a bit of a shock to see his analysis criticised as "wrong in principle" by the Supreme Court. More on that later. Now we should move on to the other aspects of the case, starting with the question of the role of the prosecution history in interpreting the scope of claims.

The file was not extensive ...

The starting point for the claims of the patent was a claim to "use of a methylmalonic acid lowering agent in the preparation of a medicament useful in lowering the mammalian toxicity associated with an antifolate, and the medicament is administered in combination with an antifolate". Here the "methylmalonic acid lowering agent" is something like vitamin B12 and the antifolate is the pemetrexed derivative.

In a first attempt at amendment of the claims during prosecution, Lilly offered limitation of the antifolate to "pemetrexed" and of the methylmalonic acid lowering agent to vitamin B12, but the examiner objected that the amendments introduced subject matter beyond that originally filed, contrary to article 123(2) EPC. Reference to "pemetrexed" did not find any basis in the application documents, which referred only to pemetrexed disodium. That, according to the examiner, is a distinct compound from pemetrexed (the free acid). In response, Lilly filed claims limited to the use of pemetrexed disodium in combination with vitamin B12. This led the Supreme Court to the consideration of two important questions: when is it permissible to have recourse to the prosecution history of a patent when considering whether a variant infringes, and whether the prosecution history in this case should alter the provisional conclusion the court had reached on direct infringement.

After looking at the comments of Lord Hoffmann in Kirin-Amgen about the undesirable consequences of permitting reference to prosecution history, and at the approach of courts in other EPC states, the court concluded that it was appropriate to take "a sceptical, but not absolutist, attitude" to reference to the prosecution file "along substantially the same lines as the German and Dutch courts". The comments of the court on the practicalities of reference to the file are interesting. They thought it was tempting to exclude the file on the basis that anyone should be entitled to rely on the content of the patent itself, without reference to other material, "as a matter of both principle and practicality". However, given that the contents of the file are publicly available, there might be occasions when justice might require reference to the file. The court seems to have been influenced in that conclusion by having been told that the contents of the file "are unlikely to be extensive". However, the circumstances in which a court can rely on the prosecution history "must be limited". That meant where (i) the point at issue is truly unclear if one confines oneself to the specification and claims, and the contents of the file would unambiguously resolve the point, or (ii) it would be contrary to the public interest for the contents of the file to be ignored. An example of (ii) would be where the patentee had made it clear to the EPO that he was not seeking to contend that his patent, if granted, would extend to the sort of variant which he now claims infringes.

Applying that to the facts of the case, the court didn't think the prosecution file justified departing from its conclusion on direct infringement. The reason the examiner thought the claims should be limited to pemetrexed disodium was because the specification did not expressly extend to any other anti-folates (although the court seemed to think the examiner was wrong about that, without explaining why). But in the court's opinion, "the whole point of the doctrine [of equivalents] is that it entitles a patentee to contend that the scope of protection "extends beyond the ambit of its claims as construed according to normal principles of interpretation".

This GuestKat has noted with interest comments which suggest that this case opens the way to a doctrine of "file wrapper estoppel" in the UK, but wonders whether the case really goes much further than existing UK case law which has admitted reference to the file in cases of "admissions against interest" - see for example Rohm & Haas v Collag [2002] F.S.R. 28 and Furr v Truline [1985] F.S.R. 553. The refusal of the court to admit reference to the file in this case is consistent with the court not regarding the limitation to the disodium salt during prosecution as determinative of whether the patentee could argue for scope of the claim to include other salts or the free acid after grant based on the reference to equivalents in Article 2 of the Protocol. Presumably the court took the view that Lilly had not "made it clear to the EPO that [it] was not seeking to contend" that the patent, if granted, would extend to other salts such as pemetrexed dipotassium.

Such an approach might open the door to more difficulty in interpreting a claim from the point of view of infringement, if one cannot decide on the question of equivalents without recourse to external resources such as expert evidence. Note that the court itself says that answering its question (ii) "does the variant nonetheless infringe because it varies from the invention in away or ways which is or are immaterial?" raises questions "which would normally have to be answered by reference to the facts and expert evidence". This seems potentially to admit far more extraneous material into the process of claim construction than reference to the file, which at least is self contained, even it may sometimes be more "extensive" than the court had been led to believe.

This GuestKat is impressed with the number of comments which the first post on this case has generated on the question of claim scope and interpretation, and thanks those who have contributed to an intelligent debate on the subject. The Supreme Court was clearly influenced in its decision by its study of the case law in other European countries, for example these quotations from the Bundesgerichtshof: that a variant will infringe if (i) “it solves the problem underlying the invention with modified but objectively equivalent means”, (ii) this would be recognised by the person skilled in the relevant art, and (iii) that person “focus[sing] on the essential meaning of the technical teaching protected in the patent” would regard the variant “as being equivalent to the solution” offered by the invention (Case No X ZR 168/00, 2002 GRUR 519 (Schneidmesser I). It seems to this GuestKat that in the context of the present case, this leads to a focus on the practical and technical solutions which an appropriately skilled person might regard as "equivalent" to the solution defined by the claim, with less regard to the actual words which the drafter has used to express that solution. It is not clear to this Kat whether this makes a patent attorney's job easier or more difficult, particularly if the object of clear wording in the claim might be to exclude embodiments which the drafter wants to exclude, for example if they fall within the prior art. It also surely means that the scope of a claim can't be definitively determined without recourse to material outside the patent specification, such as expert evidence (as considered above), which surely makes the job of advising on infringement more difficult. No doubt debate on the meaning and consequences of this decision will continue for some time to come.

Taking another pause for breath at this point, the remaining aspects of this case will be explored in Part 3 of this series.

An improved Improver? - Part 2
Reviewed by Stephen
on
Monday, July 17, 2017
Rating: 5

34 comments:

John
said...

Now that we do have a doctrine of equivalents and a limited file wrapper estoppel doctrine the UK courts may want to also look to the US where the Festo decision quite nicely thought about the interaction between the two, i.e. where a claim has been amended it cannot have doctrine of equivalents.

Presumably doctrine of equivalents is also going to have to be responsive to 'equitable' considerations in judgements since it needs to take into account patentee behaviour and decisions, such as poor drafting or attempting to use the equivalent coverage where the normal coverage could not have been obtained based on inventive step, sufficiency or added matter considerations.

It seems we have 2 things to consider/decide: - should equivalents coverage be obtained for good, honest behaviour leading to an unfair coverage being available if only the normal coverage is the only coverage- should equivalents cover variants that the patentee could not have predicted (and so did not cover with normal coverage), but which they deserve to cover due to the nature of the contribution?

This, I think, is a good case for debating whether the EPO's "Gold Standard" is fair. Does the disclosure of a document really amount to not one jot or tittle more than what the skilled reader derives from it "directly and unambiguously"? I think the answer is Yes, but I'm sure others will differ.

We look at the application as filed, which matured into the patent in suit. We look for disclosure of the key "intermediate generalization", the required intermediate layer of the onion, if you will, the one that limited the anti-folate to pemexetred (not the di-sodium class member but, rather, the pemetrexed "class" as such).

Basically, it is missing, isn't it? a bit unfortunate, that, what? So I categorize this as a case where the less than perfect drafting cost the patent owner a fortune in litigation costs, even if the owner came out OK in the end.

Applicant's diffidence, not pushing for the intermediate generalization, is very understandable. What else could he do?

The SC has displayed admirable humility and drive for international harmonization with the EPO White Book. Somehow I cannot imaging the TBA shifting from its Gold Standard any time soon. Not because of this case anyway.

The concern that assessment of infringement will require external resources is well expressed but nothing new. See for example Southco v Dzus No 1 [1989] R.P.C. 82, final paragraph:

"the guidance given in the Catnic case requires the court to conclude what would be the view of the skilled man in the art reading the specification. Even though construction is for the court, it is difficult for the court to come to a certain view as to what a skilled man would consider essential or nonessential without being educated as to the surrounding facts. This can seldom be done without evidence and cross-examination."

We now call the questions "equivalents" but we have lived with them under the guise of "purposive construction" for quite some time.

I strongly disagree that, especially this case, should be a pretext to open a discussion about the "golden standard" as defined by the TBA.

Opening Pandora's box would be fatal to the system. If national judges consider it necessary to go much further than what is actually disclosed directly and unambiguously in the original disclosure, let them do so, but such a position should not be generalised during prosecution. This is as well valid should the UPC open one day.

By this standard, multiple selection from one list and selection from two lists would be open to endless discussions in the absence of a pointer towards the chosen selection.

The same goes for intermediate generalisation. Unless the applicant/proprietor can show that at the filing date he made the corresponding invention, he should not be granted a monopoly which does not correspond to his contribution to the art.

All the proponents of such arrangements seem to forget one thing: added matter and novelty are the two faces of the same coin. What you lose out on adde matter you gain in novelty.

By the way the "White Book" is not a publication from the Boards of Appeal themselves, but from a department linked to the Boards, and the Boards do not check its content. Some interpretations do not necessarily correspond to the actual content of the decision. Before citing any part of the white book, it is advisable to check the decision itself, rather than its commentary.

As far as I can see, a determination of claim scope will now require lawyers to seek the opinion of a skilled person on two points.

Firstly, what does the skilled person understand to be covered by the wording of the claims? This is the "normal interpretation" mentioned by the SC (which, according to the House of Lords in Amgen v TKT was the only interpretation).

Secondly, the skilled person will also be asked to opine on whether an allegedly infringing embodiment represents an "immaterial variant" of the claimed invention.

The second point is an entirely new step that picks up where previously all analysis would have stopped.

If I am correct to characterise the SC's infringement test in this way, then this means that determining freedom to operate just got a whole lot more expensive (and uncertain). If you add in the HUGE unknowns (and possible flip-flopping / forum shopping) that will be introduced if and when the UPC gets up-and-running, then one could be forgiven for getting the impression that we can kiss goodbye to the concept of legal certainty for the foreseeable future.

Observer said: " Unless the applicant/proprietor can show that at the filing date he made the corresponding invention, he should not be granted a monopoly which does not correspond to his contribution to the art."

In the present case, the court found that "the inventive concept of the patent is the manufacture of a medicament which enables the pemetrexed anion to be administered with vitamin B12" (paragraph 61).

That seems to me to be a finding about the applicant's contribution to the art.

The court continued that "salt screening is a routine exercise in determining suitability, and as Floyd LJ said, 'the chemist would be reasonably confident that he would come up with a substitute for the sodium counter-ion'."

So it appears that on the basis of the applicant's contribution, a skilled person would be able to carry out the invention with the equivalents concerned.

My apologies, I must have overlooked something, and I am pleased to see that we agree on the golden standard.

Dear Tim Jackson,

I agree to the point that the court has decided what it has decided, but I maintain that what the court has decided is not what is directly and unambiguously disclosed in the application as filed. The equivalents are not part of the original disclosure.

The applicant proprietor has obtained protection for something that he has not disclosed at the filing date of his application, as he has limited himself to permetrexed disodium, whilst he would have been easy for him to show during prosecution that his specific teaching could be generalised. It was reasoned decision of his not to do so.

The uncertainty created by this decision is nothing which can be seen positively for the patent system, and I am by far not the only one who thinks so.

By definition, equivalents are never going to be the same as the literal claim.

As to the disclosure, in paragraph 89 the court seems to have had a different view to the EPO examiner about what was directly and unambiguously disclosed to the skilled person. They didn't explain why, but they had received rather more evidence than the examiner about the level of skill in this art. Maybe we can speculate that they therefore thought the disclosure would say more to a real-life skilled person than it did to the examiner.

Certainly the examiner was following the usual EPO line when deciding what was directly and unambiguously disclosed to the skilled person. Perhaps you accept the usual EPO line as the only correct one, but is it? Perhaps the gold standard should be applied after a more realistic examination of what is directly and unambiguously disclosed, giving the skilled person more credit for his or her knowledge, skill and intelligence?

And if that more realistic examination is not feasible with the limited evidence and resources available during normal examination proceedings, or even in the Boards of Appeal, perhaps the applicant should be given more benefit of the doubt, rather than just facing a brick wall.

It's a balance between, on the one hand, having some bad patents granted which may be knocked out subsequently, when the courts receive fuller evidence of the level of skill; and on the other hand having patents for meritorious inventions unduly limited so they are easy to get round and commercially worthless. I accept that there's no easy answer to achieving that balance, and it needs more debate. But I'm not convinced that the EPO and the Boards of Appeal are currently achieving it.

In the meantime, there is the doctrine of equivalents.

For the avoidance of doubt, I'm not saying the "directly and unambiguously disclosed" gold standard is necessarily wrong, but I do think we need to question and debate the mechanical way it is applied, with insufficient attention to the real knowledge and skill of a real skilled person.

And yes, I do appreciate that the same level would be applied to novelty as well as to added matter. Given that usually an inventive step is also needed, that would really only affect Article 54(3) prior art. Here is not the time or place, but one day there may be scope for a corresponding debate as to whether it should be possible to overcome 54(3) prior art by including a feature which to a skilled person is only trivially different.

we might find in 10 years that the uncertainty was great in forcing parties to talk to each other, and that led to more settlements and collaborations. One never knows what is best in the long term, and I don't think we have the best now

dif·fi·denceˈdifidəns/nounmodesty or shyness resulting from a lack of self-confidence.

Not only do you presume to know the applicant's emotional state, you presume to read into the record a causality not supported by facts of the record.

Unless you personally know of the applicant's state of self-confidence, modesty or shyness, then your suppositions merely reflect an injection of an emotional buzzword, that is simply not founded in any objective observation.

The dictionary definition from "anonymous" serves to confirm me in my self-confidence, that "diffidence" was the right word to use, to describe the Applicant's choice not to press on the ED a claim to the intermediate Generalisation pemetrexed.

By their actions shall ye know them, somebody once told us.

By the Applicant's actions here, in this way, I do know that it lacked self-confidence to press a pemetrexed claim on the ED, indeed that it shied away from even attempting it.

Applicant simply made the rational (and stink normal) assessment, that to assay a claim amendment before the ED, and fail, will leave you in a worse position after grant than if you had not tried.

That's one reason why, round the world, informal oral interviews with the responsible Examiner are so highly valued. To its credit, the EPO knows this and therefore seldom obliges.

You state: "Perhaps you accept the usual EPO line as the only correct one, but is it? Perhaps the gold standard should be applied after a more realistic examination of what is directly and unambiguously disclosed, giving the skilled person more credit for his or her knowledge, skill and intelligence?"

I will not pretend that I am most up to date with the "EPO line" on what constitutes the power of a Person Having Ordinary Skill In The Art ("PHOSITA"), but your comment DOES reflect a point that I have made on US blogs concerning the US version of that "juristic person."

To wit: our Supreme Court (in its usual manner of seeking to be anti-patent), in the KSR decision actually did the opposite - if it were to be consistent with its jurisprudence (albeit, consistency is never a given for that cloistered group).

By this I mean that by the Court attempting to raise up the power of PHOSITA in order to "allow" 103 to be more powerful in blocking patents, they also - concomitantly - raised up the power of PHOSITA when it comes to understanding what may pass as equivalents.

It is to that very same (in the US version) PHOSITA that has been augmented as to being far more powerful that THAT power now is unleashed in "understanding" what is "directly and unambiguously disclosed."

A doctrine of equivalents must mean that patentee behaviour becomes relevant to claim scope. If they explicitly 'disclaim' scope in their in validity arguments during examination then surely a Court cannot ignore that when deciding on the scope for infringement. That must mean equitable considerations apply, and the extent to which the patentee is forced to use contradictory arguments in the court case.

I don't know of any UK case law about equitable issues that would give guidance as to what UK Courts will actually do in this situation

@John - "Now that we do have a doctrine of equivalents and a limited file wrapper estoppel doctrine the UK courts may want to also look to the US where the Festo decision quite nicely thought about the interaction between the two, i.e. where a claim has been amended it cannot have doctrine of equivalents."

1) Obviously in this particular case the claims were amended due to a support issue (i.e.,they lacked support for the claim-scope that Lilly eventually succeeded in gaining by arguing equivalence), but I guess this isn't what you mean.

2) The ruling does state that an example of where the prosecution history might be of use is where the applicant has stated that something is not included in the claim scope.

Gilman Grundy, wonder what would happen if the case was assigned and the patentee going to court was different to the applicant. Are they allowed to distance themselves from the previous arguments in prosecution if they disagree with them?

What the Supreme Court is really doing is rebalancing how we determine the protection an invention deserves by focusing on what the invention is rather than the words of the claim. That has its problems but also its merits, not least because it reflects natural justice. The system has become too legalistic and literalist, where deception and cleverness with words have become too prominent. Parents must be about inventions, and we need to keep working at how best to make protection commensurate with the invention and nothing else.

@Digny - No idea. My guess would be that the assignee is buying the rights that the assignor has, and therefore is bound by what the assignor said during prosecution (which delimits the bounds of what the assignee is buying). No doubt better qualified people will be able to give you a better answer.

I think when drafting a case it might be wise now to define 'equivalents' in the description. Presumably nothing in the EPC or UK Patents Act prohibits such subject matter being present in the description and it might help to influence determination of equivalents during infringement proceedings. A court might be more minded to accept these predefined equivalents and there would have been less uncertainty for third parties which is one of the tests for how equivalents are assessed.

I fear that we will never agree, so that I think we should agree that we disagree.

It might certainly happen that examiners apply the golden standard in a mechanical way. This is not correct.

The TBA have made clear that literal support is not required by the wording of Art 123(2) EPC, see for instance T 667/08 or T 2619/11.

In T 1362/12, the BA specified that T 2619/11 did not lay down a different test, namely, of what was "really disclosed" to the skilled person. It also specified that decisions on Article 123(2) EPC are very case-specific and care should be taken in applying statements of Boards of Appeal made in the context of particular factual situations to other factual situations.

We are thus far from a mechanical application of the grounds for added subject-matter, and the route taken by the TBA has one big advantage, it offers certainty to third parties, which is certainly not the case of the decision of the SC.

As far as Art 54(3) is concerned, one way to avoid the objection, is to include an undisclosed disclaimer, cf. G1/03. G 1/16 to come, should clarify the relationship between undisclosed disclaimers (G 1/03) or disclaimers relating to an embodiment of the invention (G 2/10).

Another way to avoid an objection to Art 54(3) is to add a technical feature, whereby this feature may indeed be trivial. In my opinion, it just has to be technical, but has to be disclosed directly and unambiguously in the original application, and here no equivalents thought of by the applicant/proprietor should come into play.

In my opinion, the decision of the SC is by no way applicable in order to overcome an objection under Art 54(3). If this would be the case, then uncertainty would be even greater.

John - that "solution" is not an option for EP patents, I'm afraid. The EPO forces applicants to delete any passages in the description that cast doubt upon the scope of the claims. See, for example, the Guidelines at F.IV, 4.4 (https://www.epo.org/law-practice/legal-texts/html/guidelines/e/f_iv_4_4.htm).

To me, this kind of suggests that the SC and the EPO do not fully agree on the interpretation of Article 69 EPC... but then what do I know?

An application/patent cannot be speculative, but commensurate with the contribution to the art. Anything else would be contrary to the letter and the spirit of the patent system.

It should therefore not come as a surprise that in the absence of any proof to it, the examiner will ask that such a statement is deleted. Such a prof might be given after the filing date, but cannot be added to the original disclosure.

Ever heard of the acronym STIN on the front page of the patent? See Guidelines H-V, 2.3.

John - an interesting suggestion, and one that I would be curious to see put into practice. My experiences leads me to believe that any examiner who spotted such a statement and who appreciated its significance would either insist upon its deletion or instead upon expansion of the claims to encompass potassium salts (in addition to sodium salts). I guess we will only know if and when there is a relevant, real life example. As they say, the proof of the pudding will be in the eating.

To Observer and Proof of the Pudding, even if the statement were deleted third parties would have been given an indication of what the applicant/patentee believes the 'equivalents' scope to be, and so in litigation the infringer is less likely to win the argument on 'uncertainty' for third parties.

It's important to bear in mind how crazy this decision is. The Supreme Court seems to have got into the spirit of 'disruptive innovation' (https://en.wikipedia.org/wiki/Disruptive_innovation), perhaps because they felt judges Birss and Arnold and others were having it too easy with existing case law.

There are situation where volatility in law-making improve the system (http://scholar.harvard.edu/files/shleifer/files/evolution_jpe_final.pdf).

It will be interesting to see if future historians link this decision to the general madness of Brexit, Trump and our recent UK election. The Supreme Court were merely caught up in the zeitgeist, perhaps

My comment on the craziness of this decision is from a UK perspective. Here we had basically killed off our doctrine of equivalents (purposive construction) and were well along the road of increased literalism and zero-tolerance to ambiguity that the EPO espouses. Our younger judges (at Court of Appeal level and below) would have fallen entirely into that way of thinking and we would have been doing that for eternity had this Supreme Court decision not totally changed the direction of how we interpret claims. This is a big change for the UK, and I can tell you our patent attorneys are feeling pretty bewildered! Many feel that infringement opinions will be close to impossible to write now.

I referred to Brexit and Trump jokingly, but I do think that Brexit is giving some of the country a feeling that we now need to get back to independent thinking and not be so reliant on the EU and other International organisations to deal with the big problems. Trump being president means that decades of our foreign policy is up in the air, and the UK is requestioning what sort of country it wants to be and why. The Supreme Court may have had all this in the back of their minds when they decided to change how we interpret claims.

Well, Zeitgeist, if you live in England I must defer to you, to the extent that you know the fetid BREXIT landscape outside the South East of England better than I do. But I recall a "letter to the editor" which I read in my paper yesterday, about Brenda Hale and diversity amongst the judges. I copy its content below.

And then there's that old saying, that those looking on see more of the game than the players themselves do.

I agree that FTO opinions in chem/bio might need to be a tad more nuanced, from now on. But pemetrexed dipotassium was a pretty special case though, wasn't it. The overriding objective of doing justice necessitated stretching the scope to cover what less than perfect crafting of the patent application was lost as an undisclosed (!) intermediate Generalisation during prosecution at the EPO. It wasn't "proportionate" to strip the patent owner of all useful rights, as a punishment for a moment's inattention during the drafting of the application.

These circumstances will be rare. And it is not as if FTO opinions hitherto were dead simple to write, under "purposive construction". Divining what the drafter was using the words of the to mean is tricky enough anyway, in particular whenever the claim uses a simple engineering claim like "slide","ratchet","shoulder" or "detent".

PS. here that letter from the Reader:

......at dinner with a group of barristers, I complained that they had all led a very cloistered life – boarding school, Oxford and then into chambers.

“Not so!” said one. “I was a schoolteacher before I was a barrister.“ “Good!” said I, “Which school?”.

Here (the UK) the letter of the law is important, more so that it should be. Once a decision on a matter has issued, especially from a higher court the relevant profession falls into line. In the US, attorneys and the biotech industry is still vociferously complaining about the eligibility decisions and trying to lobby to reverse the situation. That would not have happened in the UK. The courts and the law are perceived as the authorities that know something no one else does, and so people accept the decision and start to think it and practice it. The lower Courts quickly bring it into everyday practice, i.e. it impacts a lot. Coming back to your point this will impact a lot on everyday practice, and those new Improver questions will be used frequently, and until we get much more guidance on how to use them there will be a lot of uncertainty.

I agree words are always tricky and unclear, but a lot of the time we attorneys could essentially ignore purposive construction with the knowledge it was rarely central to determining scope. Now that has changed, and that is a big deal for the UK, in my opinion.